Statisticians in Pharmaceutical Industry. Hans Ulrich Burger SSG, October 18, 2013

Transcription

1 Statisticians in Pharmaceutical Industry Hans Ulrich Burger SSG, October 18,

2 Objectives History of biostatisticians in pharmaceutical industry Important roles and tasks in drug development Opportunities for statisticians in pharmaceutical industry Career opportunities Pharmaceutical industry: A changing environment 2

3 History of biostatisticians in pharmaceutical industry Started in the 70 s 70 s and 80 s: Statisticians to a large extent employed as consultants To calculate sample sizes for studies and write related sections in the protocol No impact on analysis and trial interpretation 90 s: Take on reporting safety and efficacy Start to become integrated in development teams Last decade: Becoming more strategic Move from a statistician working in drug development to a drug developer with biostatistics background 3

4 History of biostatisticians in pharmaceutical industry Drug development today organized globally Many sites Many therapeutic areas to work on Biostatistics usually part of a larger organization frequently called biometrics Data management and statistical programming separate Biostatistics works in a metric structure on development teams together with Pharmacology and medical Scientist Operations Regulatory Research Business and production 4

5 Important roles and tasks in drug development Planning Designing drug development plans Protocol writing Strategy discussions Reporting Programming and analysis Interpretation and CSR writing Others: HA interactions and registration Drug safety Biomarker Experimental studies 5

6 Important roles and tasks in drug development Important roles Statisticians on individual studies (usually larger phase III trials) Project lead statistician for an early program Project lead statistician for a late program Technical specialists Therapeutic area leads Important is Not to be seen as a support function only but as an integral part of drug development To be seen as a strategic player 6

7 Important roles and tasks in drug development Three core competencies Statistical knowledge Key principles to control confounding factors Statistical procedures and competence to apply Good understanding of variability Drug development experience Personal competence Integrity, passion and courage Communication Ability to speak the language of our costumers Willing to speak up with confidence Networking 7

8 Further opportunities in pharmaceutical industry Non-clinical statistics Quality assurance in pharma technical (production) Marketing Pricing and health economics Marketing trials Epidemiology Disease pattern and population definition Analysis of observational studies Portfolio management 8

9 Opportunities in pharmaceutical industry (II) Note: Scientific backbone of clinical studies and other experimental settings frequently of statistical nature: This concerns as well Understanding of key principles Interpretation of data and underlying variability Statisticians needed! Word of caution: These opportunities are primarily for pharma. CROs as by today may offer different opportunities Note: Methodology is important but not necessarily in the foreground 9

10 Really important: Data interpretation 10

11 Biostatistics activities Clinical development Level 1 deliverables: Documents and analyses Level 2 deliverables: Strategic Input in Methodological excellence Input and standards for Strategic excellence Input and standards for - Protocol writing including sample size determination - DAP writing - Output control and QA - Adhoc programming - SRS and report writing - HA response analyses and writing - Analysis of pre-clinical experiments -Protocol design - Design of development program - Data interpretation - Regulatory strategy - Program conclusions - Defining key features of pre-clinical experiments - Result interpretation of pre-clinical experiments -Defining optimal analyses - Stat. Procedures - Defining optimal designs - Special methods - Adaptive designs - Bayesian designs -Protocol design - Analysis strategies - Program development strategies - Portfolio strategies - Biomarker analyses - PTS and portfolio decision making - Risk benefit strategies 11

12 Example: Career paths (Roche) Cross functional path Technical path Team lead Management path initiatives LCTL GH DSTL Senior technical expert TAGH Site head Team leader for cross functional strategies Project team lead (SH) BR Technical expert PLS Team leader for technical teams Team leader for SOP/processes teams Deputy GH FLM BSTL Deputy PLS ED lead Study Statistician 12

13 Career opportunities in clinical development Career opportunities usually within statistics There are impressive careers starting in statistics and then ending in leadership roles outside statistics Important is a decent motivation and the willingness to work independently and take on ownership An entrepreneurial mindset to go into new areas for statistics may be specifically important Career opportunities are not only in management. Leadership roles are not only in management Most important for statisticians in future probably are strategic leadership! 13

14 Changing environment Today: Business model for whole pharma industry put in question Raising cost pressure Good CRO infrastructure Increasingly good infrastructure in low cost countries Outsourcing models starting everywhere to CROs with better cost structure Other sites with better cost structure Increased pressure why we would need statisticians at main, expensive sites Development more advanced and more critical for clinical data management and programming due to smaller strategic abilities 14

15 Changing environment How should statisticians react? Diversification: Think about where statisticians could be needed Strategic component: Think about how we can show best value to an organization Participate in driving the strategy for a study, for a whole project and for the company 15

16 Changing environment In todays pharmaceutical industry statisticians who just like operational work may not have job security Statisticians have to become largely strategic Methodology Strategy What does this mean for the education Focus not only on methodology and how to do things Focus on why we do things and what are the key principles Do nothing without having understood why we need to do it! Challenge continuously current practice 16

17 Most important: Strategic impact 17

18 Thank you! 18